510(k) · Cleared
ClearedMedilas D Family Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 20, 2008 as substantially equivalent to K982629 (Dornier Surgical Products, Inc., 1998) and 3 other predicates after a 258-day review. Its family tree reaches back 9 generations to 1995. 81 later devices descend from it.
- Decided
- Aug 20, 2008
- Review
- 258 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). 81 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 1 generation backK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- This deviceK073427 Medilas D Family LasersDornier Medtech America, Inc. · 2008
- Descendant · cites it directly · 80 of its ownK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- Descendant · 2 generations on · 78 of its ownK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 2 generations on · 33 of its ownK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 1 generation backK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- This deviceK073427 Medilas D Family LasersDornier Medtech America, Inc. · 2008
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D. · 2009 · cites it directly80descendants
- K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D. · 2011 · 2 generations on78descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
- K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC · 2012 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −1 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| 0 (this device) | K073427 | Medilas D Family Lasers | Dornier Medtech America, Inc. | 2008 | — |
| +1 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| +2 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +2 | K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers… | Aerolase Medical Lasers, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 11 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982629 | Dornier Medilas DSummary page 4…Common Name: Diode Laser System Classification Name: GEX - Laser Instrument, Surgical Powered Predicate Device(s): Medilas D Compact (K982629, K003993) Medilas D fibertom (K982629, K003993) Medilas D SkinPul… | 1998 |
| * | K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse)Summary page 4…ame: Diode Laser System Classification Name: GEX - Laser Instrument, Surgical Powered Predicate Device(s): Medilas D Compact (K982629, K003993) Medilas D fibertom (K982629, K003993) Medilas D SkinPulse (K0000… | 2001 |
| * | K000072 | Dornier Medilas D SkinpulseSummary page 4…Medilas D Compact (K982629, K003993) Medilas D fibertom (K982629, K003993) Medilas D SkinPulse (K000072, K020339) Medilas D SkinPulse S / D940 (K003993, K020339) General Device The Do… | 2000 |
| * | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Summary page 4…Medilas D Compact (K982629, K003993) Medilas D fibertom (K982629, K003993) Medilas D SkinPulse (K000072, K020339) Medilas D SkinPulse S / D940 (K003993, K020339) General Device The Dornier Med… | 2002 |
What descends from it? (81)
See all 811 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model… | 2009 | 80 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K090126 (Fotona D.D., 2009) has gone furthest, with 80 descendants of its own.
- 5 other devices also cite its predicate K982629.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Med/las D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D…
Read the full statement (224 words)
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Med/las D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Med/las D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Med/las D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073427 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073427: Medilas D Family Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026